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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010899-17 | EudraCT Number |
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| Name | Class |
|---|---|
| Biologische Heilmittel Heel GmbH | INDUSTRY |
| University of Giessen | OTHER |
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To investigate and compare the effects of Traumeel®S tablets versus placebo on recovery and inflammatory immune response over a period of 72 hours after a second bout of strenuous concentric exercise on bicycle (exercise #2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traumeel | Experimental | Traumeel tablets by mouth the total amount for 72 hours will be 26 tablets |
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| Placebo | Placebo Comparator | The Placebo tablets (300 mg lactose monohydrate and 1,5 mg magnesium stearate) by mouth the total amount for 72 hours will be 26 tablets |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traumeel | Drug | oral, Day 1: one tablet every 15 minutes for two hours after the exercise test, 6 hours and 10 hours after the exercise test; Day 2 and 3: two tablets thrice daily; Day 4: two tablets in the morning |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in post-exercise two baseline levels up to 72-hours of Interleukin-1 receptor antagonist (IL-1ra) | 72 hours | |
| Changes in post-exercise two baseline levels up to 72-hours of Interleukin 6 (IL-6) | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in post-exercise two baseline levels up to 72-hours of other immunomodulators (35 lab parameters) | 72 hours | |
| Changes in post-exercise two baseline levels up to 72-hours of immune status and activation markers (7 lab parameters) | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank C. Mooren, Prof. Dr. | Department of Sports Medicine, Institute of Sports Science, University of Giessen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Sports Medicine, Institute of Sports Science, University of Giessen | Giessen | 35394 | Germany |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C433370 | Traumeel S |
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| Placebo | Drug | oral, Day 1: one tablet every 15 minutes for two hours after the exercise test, 6 hours and 10 hours after the exercise test; Day 2 and 3: two tablets thrice daily; Day 4: two tablets in the morning |
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| Changes in post-exercise two baseline levels up to 72-hours of muscle damage markers (2 lab parameters) | 72 hours |
| Changes in post-exercise two baseline levels up to 72-hours of maximum isometric strength (separately for thigh flexors and extensors) | 72 hours |
| Changes in post-exercise two baseline levels up to 72-hours Short Form McGill Questionnaire total scores and separate VAS pain ratings | 72-hours |